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The Top 5 Biosimilars Articles for the Week of January 28
The Center for Biosimilars® recaps the top news for the week of January 28, 2019.
Transcript:
Hi, I’m Samantha DiGrande for The Center for Biosimilars®, your resource for clinical, regulatory, business, and policy news in the rapidly changing world of biosimilars.
Here are the top 5 biosimilars articles for the week of January 28.
Number 5: The UK National Health Service has issued updated information on citrates in available biosimilar adalimumab.
Number 4: In observational studies of patients who have switched treatment from a reference biologic to a biosimilar, some higher rates of discontinuation may be related to the nocebo effect.
Number 3: During the CBI’s 14th Biosimilars Summit, the head of the FDA practice at Avalere said that enabling a global reference product for biosimilars would provide global access for patients.
Number 2: Bio-Thera Solutions announced that it has dosed the first patients in its phase 3 clinical study of BAT1806, a proposed biosimilar tocilizumab referencing Actemra.
Number 1: Coherus announced this week that it has become the latest biosimilar developer to settle with AbbVie, maker of brand-name adalimumab, Humira, over a proposed biosimilar. In an intellectual property twist, Coherus also announced that it has sued a rival biosimilar developer, Amgen.
Finally, last week, our e-newsletter asked if the confusion around the terms interchangeability, automatic substitution, and physician-mediated switching leads to reduced acceptance of biosimilars.
To view results of the poll, visit us on LinkedIn.
To read all of these articles and more, visit centerforbiosimilars.com.
Enhancing Adoption of Infused Biosimilars for a Sustainable Future
October 30th 2024An IQVIA report highlights challenges to the sustainability of infused biosimilars in the US, citing rebate walls and reimbursement policies, and proposes key solutions to enhance adoption and benefits for all stakeholders.
Biosimilars Policy Roundup for September 2024—Podcast Edition
October 6th 2024On this episode of Not So Different, we discuss the FDA's approval of a new biosimilar for treating retinal conditions, which took place in September 2024 alongside other major industry developments, including ongoing legal disputes and broader trends in market dynamics and regulatory challenges.
Strengthening the Supply Chain: Key Insights From FDA Commissioner Dr Robert Califf
October 25th 2024At the GRx+Biosims conference, FDA Commissioner Robert Califf, MD, stressed the urgent need for data transparency in the global supply chain and the role of collaboration and artificial intelligence in ensuring the resilience of biosimilar and generic drug production.
FDA and Industry Experts Unpack Biosimilar Device Requirements
October 23rd 2024At the GRx+Biosims 2024 conference, a panel of industry experts and FDA officials discussed evolving device requirements for biosimilars and interchangeable biosimilars, highlighting new approaches to comparative use human factors studies, regulatory challenges, and alternative validation methods.
